MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	MS930
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.Additional reporter: (b)(6).
Event or Problem Description
The event occurred on various dates from october to (b)(6) 2024 and involved a 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv clave¿, clamp, rotating luer where it was reported that the product has holes in the tubing and blood has sprayed everywhere multiple times.There was patient involvement, and no harm reported.This report captures 2 occurrences.
Additional Manufacturer Narrative
Received one used list # ms930, 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv clave¿, clamp, rotating luer; lot #14137241.As received, there was a visible crack on the female luer connected to a microclave.The reported complaint of a leak could be confirmed.The returned sample had a crack on the female luer and a leak was observed at the cracked location.The connected microclave was tested for iso standards and was within the standard.The probable cause is due to a material issue on a vendor supplied part.There is an ongoing capa related to this complaint issue at this time.Corrected information can be found in h6 medical device problem codes.Updated information can be found in h6 component code.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 20dec2024.

• Brand Name: 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20913303
• Report Number: 9617594-2024-01766
• Device Sequence Number: 20794976
• Product Code: FMG
• UDI-Device Identifier: 00887709013971
• UDI-Public: (01)00887709013971(17)290901(10)14137241
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MS930
• Device Lot Number: 14137241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown